Status:
COMPLETED
Autologous Adult Stem Cells to Patients With Type 1 Diabetes and a Successful Renal Transplant
Lead Sponsor:
Imperial College London
Conditions:
Type 1 Diabetes
Type 2 Diabetes
Eligibility:
All Genders
16-65 years
Phase:
PHASE1
Brief Summary
This is a phase I study to assess the safety and tolerability of infusing expanded stem cells into the pancreas of patients with type I diabetes and a successful renal transplant. The stem cells used ...
Detailed Description
Islet transplantation as a potential treatment for diabetes has been investigated extensively over the past 10 years. Such an approach, however, will always be limited mainly because it is difficult t...
Eligibility Criteria
Inclusion
- Male or female patients aged from 16 to 65 years of age
- Patient with Type I or Type 2 diabetes mellitus plus:
- Successful previous kidney transplant.
- Good kidney allograft function /no episodes of rejection for at least one year post-transplant
- Not taking steroids as part of standard immuno-suppression
- Has a WHO performance score of less than 2
- Has a life expectancy of at least 3 months
- Ability to give written consent
- Women of childbearing potential may be included, but must use a reliable and appropriate contraceptive method
Exclusion
- Patients below the age of 16 or above the age of 65 years
- Patients with chronic pancreatitis and poor exocrine pancreatic function
- Pregnant or lactating women
- Patients with recent recurrent GI bleeding or spontaneous bacterial peritonitis
- Patients with evidence of HIV or other life threatening infection
- Patients unable to give written consent
- Patients with a history of hypersensitivity to G-CSF
- Patients who have been included in any other clinical trial within the previous month
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00788827
Start Date
November 1 2008
End Date
May 1 2013
Last Update
November 18 2019
Active Locations (1)
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1
Imperial College NHS Healthcare Trust, Hammersmith Hospital
London, United Kingdom, W12 0HS